
Phase II of PTS100 in the treatment of Hepatocellular carcinoma (HCC) | |
Study Title |
A Phase II, Dose-randomization, Open-label Study to Assess the Safety and Efficacy of PTS in Primary Hepatocellular Carcinoma Patients Who Are Ineligible for Operation or Current Locoregional Therapy |
Study ID Numbers |
GW-020202 |
Approval number (TW) | TFDA number: 1066068608 |
Estimated Enrollment |
33 participants (Taiwan), 33 participants (Global) |
Outcome Measures |
For BCLC stage B patients with primary Hepatocellular carcinoma (HCC) who are ineligible for operation or current locoregional therapy such as TACE, to evaluate the safety and efficacy of intratumoral injection of PTS.
-To evaluate the efficacy, measured by objective response rate (ORR) of pooled treatment groups based on the modified RECIST (mRECIST) criteria at concluding visit.
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Inclusion and Exclusion Criteria (Eligibility Criteria) |
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Full clinical information link(Chinese)